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NCT01248312 · ClinicalTrials.gov registry record
Incidence of Hypercapnea in Morbidly Obese Post-Surgical Bariatric Patients Using the Sen Tec Transcutaneous PCO2 Monitor
A clinical trial, sponsored by Corewell Health East.
- Completed
- Registry status
- 22
- Enrollment target
NCT01248312 is a clinical trial that has completed, run by Corewell Health East. The registered enrollment target is 22 participants.
The verdict
NCT01248312 has completed, sponsored by Corewell Health East.
- COMPLETED
- Registry status
- 22 participants
- Enrollment target
Study Summary
Hypercapnea is a condition where there is too much carbon dioxide (CO2) in the blood. Carbon dioxide is a gaseous product of the body's metabolism and is normally expelled through the lungs (breathed out). Hypoventilation (or respiratory depression) occurs when the ventilation is inadequate to perform needed gas exchange; therefore resulting in decreased levels of oxygen and increased levels of carbon dioxide in the blood. It can cause an increased concentration of carbon dioxide and respiratory acidosis. Obesity is a multi-system disorder, particularly involving the respiratory (lungs/breathing) and cardiovascular (heart/vessel) systems. Obesity increases the risks for surgical and anesthetic complications before, during and following surgery. Bariatric (weight loss) surgery is becoming a common procedure among the morbidly obese (100 lbs or more above normal weight), with recent studies highlighting the long-term health implications of surgical weight reduction, to include a decreased risk of hypertension (high blood pressure) and diabetes (increased sugar in blood). Obese patients are at increased risk of sleep apnea (stop breathing while asleep) and hypoventilation even without surgery, and these risks increase following administration of medications typically given during and after major surgical procedures. Hypoventilation can lead to hypercapnea, sedation (sleepiness), and acidosis (blood imbalance), resulting in further respiratory compromise (breathing problems) and cardiac morbidity (heart problems) as well as the risks inherent in re-intubating (needing to have a breathing tube place down into the lungs) the obese.Monitoring for hypoventilation can be difficult. Quantitative capnography (measuring carbon dioxide) is only appropriate for intubated patients (on a ventilator - breathing tube), and pulse oximetry (clip on finger that measures oxygen levels) does not adequately detect hypoventilation in patients receiving supplemental (additional) oxygen. Ser
Interventions
- DEVICE Sentec monitoring device
- DEVICE sentec monitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-08 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01248312
The ClinicalTrials.gov registry entry for NCT01248312 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Corewell Health East, which has 106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sentec monitoring device is the first listed.
NCT01248312 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01248312 about?
NCT01248312 is a clinical study titled "Incidence of Hypercapnea in Morbidly Obese Post-Surgical Bariatric Patients Using the Sen Tec Transcutaneous PCO2 Monitor". Hypercapnea is a condition where there is too much carbon dioxide (CO2) in the blood. Carbon dioxide is a gaseous product of the body's metabolism and is normally expelled through the lungs (breathed out). Hypoventilation (or respiratory depression) occurs when the ventilation is inadequate to perfo...
What is the current status of trial NCT01248312?
This trial is currently completed. The enrollment target is 22 participants. The study started on 2010-10. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01248312?
The interventions under investigation include: Sentec monitoring device (DEVICE), sentec monitor (DEVICE).
Who is sponsoring clinical trial NCT01248312?
This trial is sponsored by Corewell Health East, which has 106 total clinical trials registered on ClinicalTrials.gov.
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